对比酶联免疫试剂与化学发光仪在血清中HIV-1HIV-2抗体中的检出价值  

To Compare the Value of ELISA and Chemiluminescence in the Detection of HIV-1HIV-2 Antibody in Serum

作　　者：高洪刚 GAO Hong-gang(Disease Prevention and Control Center of Chaisang District,Jiujiang City,Jiangxi Jiujiang 332100)

机构地区：[1]九江市柴桑区疾病预防控制中心,江西九江332100

出　　处：《中国医疗器械信息》2024年第18期35-38,共4页China Medical Device Information

摘　　要：目的:分析酶联免疫试剂与化学发光仪在血清HIV-1、HIV-2抗体中的诊断价值。方法:将院内2021年5月~2023年8月收集的101例血液样本作为本次观察对象,采取酶联免疫试剂与化学发光仪进行检验,以Western Blot作为金标准,分析酶联免疫试剂与化学发光仪对HIV-1、HIV-2抗体诊断效能,比较两者与金标准检验的Kappa值、Youden指数。结果:Western Blot检出56例HIV-1抗体阳性,另45例为阴性;酶联免疫试剂检出HIV-1抗体真阴性49例,真阳性39例,假阴性6例,假阳性7例;化学发光仪检出真阴性55例,真阳性44例,假阴性1例,假阳性1例;Western Blot检出23例HIV-1抗体阳性,另78例为阴性;酶联免疫试剂检出真阴性20例,真阳性70例,假阴性8例,假阳性3例;化学发光仪检出真阴性23例,真阳性76例,假阴性0例,假阳性2例;酶联免疫试剂HIV-1、HIV-2抗体诊断效能明显低于化学发光仪,其中化学发光仪HIV-2抗体Kappa值、Youden指数分别为0.925、0.966,HIV-1抗体Kappa值、Youden指数分别为0.867、0.903均高于酶联免疫试剂,对比差异有统计学意义(P<0.05)。结论:血清HIV-1、HIV-2抗体检测中化学发光仪具有较高的诊断效能,其灵敏度、特异度、阴性预测值等较酶联免疫试剂更高,可作为抗体检测方式,为疾病预测诊断提供参考。Objective:To analyze the diagnostic value of ELISA and chemiluminescence apparatus in serum HIV-1 and HIV-2 antibodies.Methods:The 101 blood samples collected in the hospital from May 2021 to August 2023 were taken as the objects of this observation,and were tested by ELISA and chemiluminescence apparatus.Western Blot was used as the gold standard to analyze the diagnostic efficacy of ELISA and chemiluminescence apparatus on HIV-1 and HIV-2 antibodies.The Kappa value and Youden index were compared with the gold standard test.Results:Western Blot detected HIV-1 antibody positive in 56 cases and negative in 45 cases.Enzyme linked immunosorbent assay detected 49 true negative cases,39 true positive cases,6 false negative cases,and 7 false positive cases of HIV-1 antibodies;Chemiluminescence detected true negative in 55 cases,true positive in 44 cases,false negative in 1 case,false positive in 1 case;Western Blot analysis showed that 23 cases were positive for HIV-1 antibody and 78 cases were negative.Elisa detected true negative in 20 cases,true positive in 70 cases,false negative in 8 cases and false positive in 3 cases.There were 23 true negative cases,76 true positive cases,0 false negative cases and 2 false positive cases detected by chemiluminescence.The diagnostic efficiency of HIV-1 and HIV-2 antibody of ELISA was significantly lower than that of chemiluminescence instrument,and the Kappa value and Youden index of HIV-2 antibody of chemiluminescence instrument were 0.925 and 0.966,respectively.HIV-1 antibody Kappa value and Youden index of 0.867 and 0.903 were higher than those of ELISA,and the difference was statistically significant(P<0.05).Conclusion:Chemiluminescence instrument has higher diagnostic efficacy in detection of serum HIV-1 and HIV-2 antibodies,and its sensitivity,specificity and negative predictive value are higher than that of ELISA.It can be used as antibody detection method to provide reference for disease prediction and diagnosis.

关 键 词：酶联免疫试剂 化学发光仪 HIV-1 HIV-2 

分 类 号：R446.1[医药卫生—诊断学]